| CTRI Number |
CTRI/2025/08/092446 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
compare the effect of cupping with Roghan-e-Babuna and Short Wave Diathermy in non-specific low back pain.
|
|
Scientific Title of Study
|
A randomized comparative clinical study to evaluate the effect of Hijama Mutaharrika with Roghan-e-babuna and Short- wave diathermy in the management of Waja’al- zahr (non-specific low back pain).
|
| Trial Acronym |
LBP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mantasha Khan |
| Designation |
PG scholar |
| Affiliation |
State unani medical college and hospital, Himmatganj,Prayagraj, Uttar pradesh (211016) |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT), State unani medical college and hospital, Himmatganj,Prayagraj, Uttar pradesh (211016)
Allahabad
UTTAR PRADESH
211016
India
Department of Ilaj-Bit-Tadbeer (IBT), State unani medical college and hospital, Himmatganj,Prayagraj, Uttar pradesh (211016)
Allahabad
UTTAR PRADESH
211016
India
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
7985601983 |
| Fax |
|
| Email |
khanmantasha1506@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bushra Aftab |
| Designation |
Reader |
| Affiliation |
State unani medical college and hospital, Himmatganj,Prayagraj, Uttar pradesh (211016) |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT), State unani medical college
and hospital, Himmatganj,Prayagraj, Uttar pradesh (211016)
Allahabad
UTTAR PRADESH
211016
India
Department of Ilaj-Bit-Tadbeer (IBT), State unani medical college
and hospital, Himmatganj,Prayagraj, Uttar pradesh (211016)
Allahabad
UTTAR PRADESH
211016
India
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
8279747882 |
| Fax |
|
| Email |
drbushraaftab@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bushra Aftab |
| Designation |
Reader |
| Affiliation |
State unani medical college and hospital, Himmatganj,Prayagraj, Uttar pradesh (211016) |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT), State unani medical college
and hospital, Himmatganj,Prayagraj, Uttar pradesh (211016)
Allahabad
UTTAR PRADESH
211016
India
Department of Ilaj-Bit-Tadbeer (IBT), State unani medical college
and hospital, Himmatganj,Prayagraj, Uttar pradesh (211016)
Allahabad
UTTAR PRADESH
211016
India
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
8279747882 |
| Fax |
|
| Email |
drbushraaftab@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
State unani medical college and hospital |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT), State unani medical college
and hospital, Himmatganj,Prayagraj, Uttar pradesh (211016) |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mantasha Khan |
State unani medical college and hospital, Himmatganj,Prayagraj, Uttar pradesh (211016) |
Room no. 4, ground floor, Department of Ilaj-Bit-Tadbeer (IBT), State unani medical college
and hospital, Himmatganj,Prayagraj, Uttar pradesh (211016)
Allahabad
UTTAR PRADESH |
7985601983
khanmantasha1506@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hijama Mutaharrika (Gliding cupping) |
in this procedure, massage oil is applied to the affected area. A sterilized cup is then carefully placed and a slight negative pressure (half and one pull) is created with a manual pump. The cup is glided over the area for 5 minutes. afterthat four cups are placed on the lumbosacral region and
left for another 5 minutes. finally, the cup is removed following standard cupping removal procedures. |
| Comparator Agent |
Short wave Diathermy (SWD) |
Patient of this group will be treated with Short-wave Diathermy. The condenser
of pads of short- wave diathermy will be applied on lumbosacral region with 1 or 2 inch space between skin and pads provided by tarry cloths and left for 10 min. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to participate in the study and follow the instruction.
2. Age group 20 to 60 years.
3. Patients of both genders.
4. No radiation of low back pain in other region.
5. Clinically or radiologically diagnosed patients of waja’al-zahr.
6. ODI scoring: 10 percent to 60 percent (mild to severe)
7. No apparent spine deformity like Kyphosis, Scoliosis and Lordosis etc.
8. BMI more than 29kg/m2. |
|
| ExclusionCriteria |
| Details |
1. Patient below age 20 years and above 60 years
2. H/O Tumor or malignancy
3. Pregnant and lactating women
4. Diabetic and Hypertensive patients
5. Patient of Rheumatoid Arthritis and Gout.
6. H/O Trauma or surgery of lumbosacral region
7. Patient on steroid therapy
8. Patients taking analgesic drug treatment in
past one week. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. VAS
2. Oswestry low back pain questionnaire. |
7th,14th,21st,28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SF36
|
0 to 28th days. |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Low back pain is a prevalent issue worldwide affecting numerous individuals in modern times. In Unani system of medicine Waja occurs due to abrupt changes in the temperament of Su e mizaj Mukhtalif and Tafarruq e Ittesal. The newly developed abnormal temperament becomes hot or cold contrary to the original temperament and causes pain. Low back pain is a disease in which pain arises from internal and external muscles and ligaments surrounding the lumbar and lumbosacral region. It is a common disorder in urban and rural population, which is associated with substantial morbidity for about 80 percent of the general population not only in industrialized world but also in rural communities. Low back pain is divided into two categories: 1. Specific 2. non- specific. In specific low back pain the cause can be detected and In Non-specific low back pain there is no specific cause can be detected. The prevalence of LBP is also concerning in India affecting nearly 60 percent of the population at some point of their lives.The annual occurrence of the low back pain is estimated 5 percent per year, leading to prevalence ranging from 60 to 90 percent. This condition limits the functional ability, impacting occupational activities and imposing a significant socio-economic burden. In Allopathic system of medicine initial treatment of low back pain often involve the use of certain topical and systemic analgesics and anti-inflammatory drugs such as Acetaminophen, NSAIDS and steroid therapy. Though, they relieve pain and symptoms with high recurrence ratealong with causing certain adverse effects like hepatotoxicity, nephrotoxicity and gastrointestinaltoxicity. As there seems to be lack of permanent relief solution and need for alternative approaches that are both effective and safe. There are different kind of treatment in the Unani system of medicine which are more effective than Allopathic system of medicine. In Ilaj-Bit- Tadbeer various regimens such as- Hijama (cupping), Dalk(massage), Abzan(sitz bath) and Fasd(Venesection), Nutool (irrigation), riyazat (exercise) and taleeq(leeching ) etc. are more effective and devoid of any side effect. |